COVERAGE SPRAY HBV
Device Facts
| Record ID | K964835 |
|---|---|
| Device Name | COVERAGE SPRAY HBV |
| Applicant | Convatec, A Division of E.R. Squibb & Sons |
| Product Code | LRJ · General Hospital |
| Decision Date | Dec 16, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6890 |
| Device Class | Class 1 |
Indications for Use
Coverage Spray HBV is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in healthcare facilities.
Device Story
Coverage Spray HBV; liquid chemical germicide; active ingredients quaternary ammonium chloride compounds. Applied to hard inanimate surfaces and reusable non-critical medical devices in healthcare facilities. Inactivates specific bacteria, fungi, and viruses. Used by healthcare personnel for environmental and equipment disinfection. Benefits patient by reducing risk of cross-contamination via surface contact.
Clinical Evidence
Bench testing only. Safety data: Acute Oral LD50 (rats) 5,000 mg/kg; Acute Dermal LD50 >2,000 mg/kg; Dermal Irritation (rabbit) mild transient; Eye Irritation (rabbit) mild transient; Dermal Sensitization (guinea pig) negative. Effectiveness: EPA-approved for S. aureus, S. choleraesuis, Ps. aeruginosa, pathogenic fungi, Aspergillus niger, Hepatitis B, HIV-1, Herpes simplex 1/2, Parainfluenza 1, Pseudorabies, Influenza A2, Influenza B, and Measles.
Technological Characteristics
Liquid chemical germicide; active ingredients: quaternary ammonium chloride compounds.
Indications for Use
Indicated for use on hard inanimate surfaces and reusable non-critical medical devices in healthcare facilities to inactivate bacteria, fungi, and viruses.
Regulatory Classification
Identification
A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.
Predicate Devices
- Tor Germicidal Cleaner (Huntington Laboratories)
- Quat-Syl 256 (National Laboratories)
- Futron 25 (Hysan Corp.)
Related Devices
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- K962739 — T.B.Q. · Convatec, A Division of E.R. Squibb & Sons · Oct 7, 1996
- K974304 — GERMICIDAL CLOTH · Convatec, A Division of E.R. Squibb & Sons · Jan 13, 1998
- K980369 — T.B.Q. RTU · STERIS Corporation · Feb 17, 1998
- K981023 — KLEENASEPTIC · Metrex Research Corp. · Apr 30, 1998
